System, apparatus and method for supplying gases

ABSTRACT

A system, apparatus and methods are provided for supplying gases to a user. The supply includes a sub-therapeutic mode and a pressure support mode for delivering therapy to a user. A flow diversion device or valve switches from a first mode corresponding with the sub-therapeutic mode of the system to a second mode corresponding with the pressure support mode of the system. In the first mode, the valve opens a larger flow path between the interior of the user interface and ambient air than in the second mode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit under 35 U.S.C. § 119(e) ofU.S. Provisional Application No. 61/419,421, filed on Dec. 3, 2010,which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally relates to apparatus and methods forsupplying respiratory gas under positive pressure to a sleeping user,such as in the treatment of obstructive sleep apnea (OSA). Moreparticularly, the present invention relates to such apparatus andmethods in which a condition of a user's body is sensed. Even moreparticularly, the present invention relates to such apparatus andmethods featuring a gas supply that is responsive to breathing and thatincludes a valve in the control mechanism.

Description of the Related Art

A common method of treating obstructive sleep apnea (OSA) involves apressure device that provides breathing gases, typically air, to a user(often referred to as the patient) while the user is asleep. Thesemachines fall into the broad classification of PAP (positive airwaypressure) devices or CPAP (continuous PAP) devices.

Within this broad classification, there are wide variations. Forexample, some machines provide different pressure during userinspiration than during user expiration (Bi PAP), some machines providean auto-setting or autotitrating mode, wherein the supplied pressurevaries through the period of use in response to detected events. In thiscontext, detected events may include snoring, hypopneas and obstructivebreathing. Some machines respond to user awakening and mask removal, forexample, by reducing the delivered pressure. Some machines deliver apredetermined set pressure, which may be delivered at the same pressurenight after night or which may be varied night by night by physicaladjustment or by automatic adjustment by the unit. Some machines includea ramp function that begins automatically or that begins by userselection. The ramp function causes the machine to commence operation ata low pressure, which is sometimes settable, and to gradually increaseto a higher pressure, which may be a predetermined treatment pressure orwhich may be an intermediate pressure.

The machines typically provide controlled pressure delivery. Forexample, the machines typically include a flow generator, a pressuresensor that senses the pressure being delivered to the user, and afeedback control that controls the output of the flow generator basedupon a sensor signal so that the sensed pressure is maintained close toa demand pressure. Alternatively, the flow generator may include a fanthat generates a known pressure and flow response. The output of theflow generator can be controlled to deliver a desired pressure usingfeedback from a flow sensor in a circuit that is connected to the flowgenerator. Alternatively, the flow generator may include a fan thatprovides a substantially uniform pressure at a given rotation speedacross a useful range of flow. Pressure then can be controlled bysetting a constant motor speed.

Even for the lower pressure at the start of a ramp cycle, most of themachines supply a minimum pressure of 3 cmH2O or more. The minimumpressure is more comfortable for the user than the full treatmentpressure and results in a sufficient flow of breathing gases through asupply line to the user so that breathing gases exit through a bias flowor a controlled leak port provided at or near a user interface that isconnected to the supply line.

SUMMARY OF THE INVENTION

An object of the present invention is to provide apparatus or method forproviding breathing gases to a user, which at least go someway towardimproving on prior systems, or which will at least provide users with auseful choice.

In some configurations, an apparatus comprises a flow generator and acontroller connected to control the output of the flow generator. Aconduit extends from the flow generator to connect with a user interfacewith the inside of the conduit and the inside of the user interfacedefining a gases space. A valve positioned at or adjacent the userinterface. The valve being switchable between a first mode in which thegases space is significantly open to ambient through the valve and asecond mode in which the gases space is not significantly open toambient through the valve. The controller including one or more positiveairway pressure support modes in which the controller may cause the flowgenerator to deliver pressure support to the airway of a user with thevalve in the second mode and the controller including one or moresub-therapeutic modes in which the controller may cause the flowgenerator to deliver flow of gases to the user with the valve in thefirst mode.

The valve can include an aperture that communicates the gases space withambient and a valve member that, in a second position, closes theaperture and is substantially out of the flow path of gases through theconduit or interface and, in a first position, leaves the aperture openfor substantially unimpeded flow from the interface to the ambient.

In the first position, the valve member may partially, but not fully,occlude flow from the flow generator to the interface. In someconfigurations, the first position of the valve comprises the valvebeing bent towards the user when the user is inhaling. In someconfigurations, the first position of the valve comprises the valvebeing bent toward the flow generator when the user is exhaling.

The valve member when in the first position preferably occludes betweenabout 50% and about 80% of a cross-sectional area of a flow path fromthe flow generator to the user interface.

The positive airway pressure support modes can include a supply of gasesto a user such that, with the valve in the first mode, the flowgenerator provides enough flow to the user interface such that with theinterface worn by a user a pressure greater than about 3 cm H2O isproduced.

A sensor can be included to derive a measure of pressure in the gasesspace such that in a positive airway pressure mode the controllercontrols output of the flow generator according to a command pressureand feedback from the sensor for deriving the measure of pressure in thegases space.

In some configurations, in the sub-therapeutic mode, the controllerprovides a flow to the interface that is not sufficient to force thevalve into the closed position.

In the sub-therapeutic mode, the controller can cause the flow generatorto provide a flow greater than about 5 litres per minute (mostpreferably greater than about 10 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow less than about 20 litresper minute (most preferably less than 15 litres per minute).

The valve can move from the first mode to the second mode upon risingthrough a first threshold of flow/pressure, and from the second mode tothe first mode on falling through a second threshold of flow/pressure,wherein the first threshold of flow/pressure is higher than the secondthreshold of flow/pressure.

In some configurations, with the valve in the first mode and thecontroller operating in the sub-therapeutic mode, the valve can remainstable for flows up to at least about 20 litres per minute, withdelivered pressures below about 2 cm H2O.

With the valve in the second mode, and the controller operating in thepressure support mode, the valve can remain stable at pressures down toabout 3 cm H2O or lower.

In some configurations, the lowest pressure for which the valve isstable in the second mode when the controller is in the pressure supportmode is less than about 1 cm H20 above the average delivered pressurewhen the valve is in the first mode and the controller is in thesub-therapeutic mode supplying about 15 litres per minute.

In some configurations, in the sub-therapeutic mode, the controllercontrols the flow generator to deliver an average flow at a level thatassures flushing of the user interface but which does not trigger thevalve to switch from the first mode to the second mode.

In some configurations, the controller controls the flow generator toprovide an average flow over multiple breaths that is substantiallyconstant.

In some configurations, an apparatus comprises a flow generator and acontroller connected to control the output of the flow generator. Aconduit extends from the flow generator to connect with a userinterface. The inside of the user interface defines a gases space. Avalve at or adjacent the user interface is switchable between a firstmode, in which the gases space is open to ambient through the valve, anda second mode, in which the gases space generally is not open to ambientthrough the valve. Control of the flow generator and the constructionand arrangement of the valve can be such that in a period of transition(in either direction) between a pressure support delivery to the userand a sub-therapeutic supply to the user, user breathing does nottrigger repeated cycling between the first mode and the second mode.

The controller can include one or more positive airway pressure supportmodes in which the controller may cause the flow generator to deliverpressure support to the airway of a user with the valve in the secondmode and one or more sub-therapeutic modes in which the controller maycause the flow generator to deliver flow of gases to the user with thevalve in the first mode.

In some configurations, the one or more positive airway pressure modesinclude supply of gases to the user such that, with the valve in theclosed position, the flow generator provides enough flow to the userinterface such that, with the interface worn by a user, a pressuregreater than about 3 cm H2O is produced.

A sensor can be provided to derive a measure of pressure in the gasesspace wherein, in a positive airway pressure mode, the controllercontrols the output of the flow generator according to a commandpressure and feedback of the measure of pressure in the gases space fromthe sensor.

In some configurations, in the sub-therapeutic mode, the controllerprovides a flow to the interface that is not sufficient to force thevalve into the first mode.

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow greater than about 5 litresper minute (most preferably greater than about 10 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow less than about 20 litresper minute (most preferably less than about 15 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercontrols the flow generator to deliver an average flow at a level thatassures flushing of the user interface, but which does not trigger thevalve to switch from the first mode to the second mode.

The controller can control the flow generator to provide an average flowover multiple breaths that is substantially constant.

The valve can include an aperture communicating the gases space withambient and a valve member that in a first position closes the apertureand is out of the flow path of gases through the conduit or interfaceand in a second position leaves the aperture open for substantiallyunimpeded flow from the interface to the ambient.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the flow generator to theinterface.

In some configurations, in the second position, the area valve memberoccludes between about 50% and about 80% of a cross sectional area of aflow path from the flow generator to the user interface.

In some configurations, the valve moves from the first mode to thesecond mode upon rising through a first threshold of flow/pressure, andfrom the second mode to the first mode on falling through a secondthreshold of flow/pressure, wherein the first threshold of flow/pressureis higher than the second threshold of flow/pressure.

In some configurations, with the valve in the first mode and thecontroller operating in the sub-therapeutic mode, the valve remainsstable for flows up to at least about 20 litres per minute withdelivered pressures below about 2 cm H2O.

In some configurations, with the valve in the second mode and thecontroller operating in the pressure support mode, the valve remainsstable at pressures down to about 3 cm H2O or lower.

In some configurations, the lowest pressure for which the valve isstable in the second mode when the controller is in the pressure supportmode is less than about 1 cm H2O above the average delivered pressurewhen the valve is in the first mode and the controller is in thesub-therapeutic mode supplying about 15 litres per minute.

In some configurations, an apparatus comprises a flow generator, acontroller connected to control the output of the flow generator, and aconduit extending from the flow generator to connect with a userinterface with the inside of the conduit and the inside of the userinterface defining a gases space. A valve can be positioned at oradjacent the user interface and can include an aperture communicatingthe gases space with ambient and a valve member wherein, in a firstposition, the valve member leaves the aperture substantially open forflow from the interface to the ambient and, in a second position, thevalve member closes the aperture, and wherein the valve member movesfrom the first position to the second position upon rising through afirst threshold of flow/pressure, and from the second position to thefirst position on falling through a second threshold of flow/pressure,wherein the first threshold of flow/pressure is higher than the secondthreshold of flow/pressure.

The controller can include one or more positive airway pressure supportmodes in which the controller causes the flow generator to deliverpressure support to the airway of a user with the valve in the secondmode and one or more sub-therapeutic modes in which the controllercauses the flow generator to deliver flow of gases to the user with thevalve in the first mode.

The positive airway pressure modes can include supply of gases to theuser such that, with the valve in the closed position, the flowgenerator provides enough flow to the user interface such that, with theinterface worn by a user, a pressure greater than about 3 cm H2O isproduced.

A sensor can be provided to obtain a measure of pressure in the gasesspace such that, in a positive airway pressure mode, the controllercontrols the output of the flow generator according to a commandpressure and feedback of the measure of pressure in the gases space fromthe sensor.

In some configurations, in the sub-therapeutic mode, the controllerprovides a flow to the interface that is not sufficient to force thevalve into the closed position.

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow greater than about 5 litresper minute (most preferably greater than about 10 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow less than about 20 litresper minute (most preferably less than about 15 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercontrols the flow generator to deliver an average flow at a level thatassures flushing of the user interface but which does not trigger thevalve to switch from the first position to the second position.

In some configurations, the controller controls the flow generator toprovide an average flow over multiple breaths that is substantiallyconstant.

In some configurations, with the valve in the first position and thecontroller operating in the sub-therapeutic mode, the valve remainsstable for flows up to at least about 20 litres per minute withdelivered pressures below about 2 cm H2O.

In some configurations, with the valve in the second position and thecontroller operating in the pressure support mode, the valve remainsstable at pressures down to about 3 cm H2O or lower.

In some configurations, the lowest pressure for which the valve isstable in the second position when the controller is in the pressuresupport mode is less than about 1 cm H2O above the average deliveredpressure when the valve is in the first position and the controller isin the sub-therapeutic mode supplying about 15 litres per minute.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the flow generator to theinterface.

In some configurations, in the second position, the valve memberoccludes between about 50% and about 80% of a cross sectional area of aflow path from the flow generator to the user interface.

In some configurations, an apparatus comprises a flow generator, acontroller connected to control the output of the flow generator, and anasal mask for covering nasal passages of a wearer but leaving a mouthuncovered. A conduit extends from the flow generator to connect with thenasal mask with the inside of the conduit and the inside of the nasalmask defining a gases space. A valve is positioned at or adjacent thenasal mask which is switchable between a first mode, where the gasesspace is open to ambient through the valve, and a second mode, where thegases space is not open to ambient through the valve. The controllercontrols the flow generator to deliver gases through the conduit withthe valve in the first mode and with the valve in the second mode.

The controller can include one or more positive airway pressure supportmodes in which the controller may cause the flow generator to deliverpressure support to the airway of a user with the valve in the secondmode, and one or more sub-therapeutic modes in which the controller maycause the flow generator to deliver flow of gases to the user with thevalve in the first mode.

The positive airway pressure modes can include supply of gases to theuser such that, with the valve in the first mode, the flow generatorprovides enough flow to the user interface such that, with the interfaceworn by a user, a pressure greater than 3 cm H2O is produced.

A sensor can be provided for deriving a measure of pressure in the gasesspace where, in a positive airway pressure mode, the controller controlsthe output of the flow generator according to a command pressure andfeedback of the measure of pressure in the gases space.

In some configurations, in the sub-therapeutic mode, the controllerprovides a flow to the interface that is not sufficient to force thevalve into the second mode.

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow greater than about 5 litresper minute (most preferably greater than about 10 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercauses the flow generator to provide a flow less than about 20 litresper minute (most preferably less than about 15 litres per minute).

In some configurations, in the sub-therapeutic mode, the controllercontrols the flow generator to deliver an average flow at a level thatassures flushing of the user interface but that does not trigger thevalve to switch from the first mode to the second mode.

In some configurations, the controller controls the flow generator toprovide an average flow over multiple breaths that is substantiallyconstant.

In some configurations, the valve includes an aperture communicating thegases space with ambient and a valve member that is moveable between afirst position corresponding to the second mode and a second positioncorresponding to the first mode, the valve member in the first positionclosing the aperture and being positioned out of the flow path of gasesbetween the valve inlet and the valve outlet, and the valve member in asecond position leaving the aperture open for substantially unimpededflow from the valve inlet to ambient.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the valve inlet to thevalve outlet.

In some configurations, in the second position, the valve memberoccludes between about 50% and about 80% of a cross sectional area of aflow path from the valve inlet to the valve outlet.

In some configurations, the valve moves from the first mode to thesecond mode upon rising through a first threshold of flow/pressure, andfrom the second mode to the first mode on falling through a secondthreshold of flow/pressure, wherein the first threshold of flow/pressureis higher than the second threshold of flow/pressure.

In some configurations, with the valve in the first mode and thecontroller operating in the sub-therapeutic mode, the valve remainsstable for flows up to at least about 20 litres per minute withdelivered pressures below 2 cm H2O.

In some configurations, with the valve in the second mode and thecontroller operating in the pressure support mode, the valve remainsstable at pressures down to about 3 cm H2O or lower.

In some configurations, the lowest pressure for which the valve isstable in the second mode when the controller is in the pressure supportmode is less than about 1 cm H2O above the average delivered pressurewhen the valve is in the first mode and the controller is in thesub-therapeutic mode supplying about 15 litres per minute.

A valve can be provided for use at or adjacent a user interface. Thevalve comprises a flow passage defined by at least one wall. The flowpassage extends between a valve inlet and a valve outlet configured toopen toward the user interface. An aperture through the at least onewall defines the flow passage. The aperture is positioned between thevalve inlet and the valve outlet with a valve member being positionedbetween the valve inlet and the aperture. The valve member is movablebetween a first position and a second position. The valve member in thefirst position leaving the aperture open for flow from the interface toambient and the valve member in the second position closing theaperture. The valve member is adapted to move from the first position tothe second position upon rising through a first threshold offlow/pressure in the flow passage, and the valve member is adapted tomove from the second position to the first position on falling through asecond threshold of flow/pressure in the flow passage, wherein the firstthreshold of flow/pressure is higher than the second threshold offlow/pressure.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the valve inlet to thevalve outlet.

In some configurations, in the second position, the valve memberoccludes between 50% and 80% of a cross sectional area of a flow pathfrom the valve inlet to the valve outlet.

A valve can be provided for use at or adjacent a user interface. Thevalve comprises a flow passage at least partially defined by a wall. Theflow passage extends between a valve inlet and a valve outlet that isadapted to be fluidly connected to the user interface. An aperture isdefined through the wall. The aperture is positioned between the valveinlet and the valve outlet with a valve member being positioned betweenthe valve inlet and the aperture. The valve member is movable between afirst position and a second position. When the valve member is in thefirst position, the aperture is left open for flow from the interface toambient. When the valve member is in the first position, flow ispartially but not fully occluded through the flow passage. When thevalve member is in the second position, the aperture is substantiallyclosed. The valve member in the first position occludes between about50% and about 80% of a cross section area of a flow passage between theinlet and the outlet at the valve member.

In some configurations, a cross-sectional area of the flow passagethrough the valve at the valve member is between about 40 mm2 and about250 mm2.

In some configurations, the area of the aperture is between about 10%and about 50% of the cross sectional area of the flow passage throughthe valve.

In some configurations, the area of the aperture is between about 15%and about 25% of the cross sectional area of the flow passage throughthe valve.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the flow generator to theinterface.

In some configurations, in the second position, the area valve memberoccludes between about 50% and about 80% of the area of the flow pathfrom the flow generator to the user interface.

A valve can be provided for use at or adjacent a user interface. Thevalve comprises a flow passage defined by a wall. The flow passageextends between a valve inlet and a valve outlet. An aperture is definedthrough the wall. The aperture is positioned between the valve inlet andthe valve outlet. A valve member is positioned between the valve inletand the aperture. The valve member is movable between a first positionand a second position, wherein the valve member in the first positionleaving the aperture open for flow from the user interface to ambient,the valve member in the second position at least partially closing theaperture, and the valve member being stable in the first position underuser breathing for average flows over multiple breaths of up to 30litres per minute, delivering a pressure below about 1.5 cm H2O, andbeing stable in the second position under user breathing for controlledpressures above about 1.7 cm H2O.

In some configurations, a cross-sectional area of the flow passagethrough the valve from the inlet to the outlet is between about 350 mm2and about 600 mm2.

In some configurations, the area of the aperture is between 10% and 50%of a cross-sectional area of the flow passage through the valve.

In some configurations, the area of the aperture is between 15% and 25%of the cross sectional area of the flow passage through the valve.

In some configurations, in the second position, the valve memberpartially, but not fully, occludes flow from the flow generator to theinterface.

In some configurations, in the second position, the valve memberoccludes between about 50% and about 80% of a cross sectional area ofthe flow path from the flow generator to the user interface.

In some configurations, a system is provided for supplying respiratorygases to a user wearing a user interface. The system comprises a flowgenerator and a controller adapted to control operation of the flowgenerator. The flow generator has a flow control mode and a pressurecontrol mode. The flow control mode comprises generation of asub-therapeutic flow of gases and the pressure control mode comprisesgeneration of a therapeutic flow of gases. A flow diversion valve ispositioned between the flow generator and the user interface. The flowdiversion valve comprises a flow channel and an aperture. The apertureplaces the flow channel in fluid communication with ambient. The flowdiversion valve further comprises a valve member that is cantileveredfrom a wall and that extends toward the flow channel in a firstposition. The valve member is moveable between the first position and asecond position. The valve member overlies at least a portion of theaperture in the second position and the valve member occludes only aportion of the flow channel in the first position. The valve member ismovable from the first position to the second position when the flowgenerator transitions from the flow control mode to the pressure controlmode and movable from the second position toward the first position whenthe flow generator transitions from the pressure control mode to theflow control mode.

In some configurations, the valve member does not abut a valve seat inthe first position.

In some configurations, the valve member is in the first position whenthere is no flow through the flow channel and the valve member does notabut a valve seat in the first position. In some configurations, thefirst position of the valve comprises the valve being bent towards theuser when the user is inhaling. In some configurations, the firstposition of the valve comprises the valve being bent toward the flowgenerator when the user is exhaling.

In some configurations, the valve member when in the first positionoccludes between about 50% and about 80% of a cross-sectional area ofthe flow channel.

In some configurations, the flow control mode comprises delivering anaverage flow rate of between about 15 litres per minute and about 17litres per minute.

In some configurations, the flow control mode comprises delivering apressure of less than about 4 centimeters water.

In some configurations, the valve member abuts a land in the secondposition.

In some configurations, the land is offset inwardly toward the flowchannel from a portion of the valve member that is secured to a body ofthe valve.

In some configurations, the aperture defines an opening with across-sectional area of about 90 mm2.

To those skilled in the art to which the invention relates, many changesin construction and widely differing embodiments and applications of theinvention will suggest themselves without departing from the scope ofthe invention as defined in the appended claims. The disclosures and thedescriptions herein are purely illustrative and are not intended to bein any sense limiting.

The term “comprising” is used in the specification and claims, means“consisting at least in part of.” When interpreting a statement in thisspecification and claims that includes “comprising,” features other thanthat or those prefaced by the term may also be present. Related termssuch as “comprise” and “comprises” are to be interpreted in the samemanner.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention will now be described with reference to the drawings ofpreferred embodiments, which embodiments are intended to illustrate andnot to limit the invention, and in which figures:

FIG. 1 is a flow diagram illustrating a control method that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention and that can be implemented by acontroller of a gas supply apparatus.

FIG. 2 is a block diagram illustrating a gases supply system that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 3a and FIG. 3b are two non-limiting examples of plots of pressureand flow against time for portions of a session using an apparatus thatis arranged and configured in accordance with certain features, aspectsand advantages of the present invention.

FIG. 4 is a block diagram of an experimental setup used to evaluatemachines arranged and configured in accordance with certain features,aspects and advantages of the present invention.

FIGS. 5A to 5F are plots that show opening and closing characteristicsof a flow diversion device that is arranged and configured in accordancewith certain features, aspects and advantages of the present invention.

FIGS. 6A to 6F are plots that show opening and closing characteristicsof a flow diversion device that is arranged and configured in accordancewith certain features, aspects and advantages of the present invention.

FIGS. 7A and 7B are plots that show flow and pressure versus time foreach of two valves and illustrate differences in the valvecharacteristic between the two valves.

FIGS. 8A and 8B are plots that show flow and pressure versus time thatillustrate differences between operating in a flow control mode when thevalves are on the verge of closing and operating in a pressure controlmode.

FIG. 9A is a cross-sectional side elevation of a flow diverting valvethat is arranged and configured in accordance with certain features,aspects and advantages of the present invention.

FIG. 9B is a perspective view of the valve of FIG. 9A.

FIG. 9C is a cross-section of the value of FIG. 9A showing a profile ofthe valve.

FIG. 10A is a side perspective view of a flow diverting valve that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 10B is cross-sectional top view of the valve of FIG. 10A.

FIG. 10C is a sectioned view of the valve of FIG. 10A taken along theline C-C in FIG. 10B.

FIG. 10D is a perspective view of the sectioned valve of FIG. 10C.

FIG. 11 is a graphical representation of an impact of valve orificesizes on flow rates.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description presents a system, and elements of thatsystem, that can provide an alternative to a defined pressure ramp atthe commencement of a treatment session. The system, and the elements ofthat system, also can provide an alternative to low therapeuticpressures (i.e., awake pressures) at other times when a user (i.e.,user) is thought to be awake.

Certain features, aspects and advantages of the present invention relateto a sub-therapeutic control mode in which the user receives maskpressures that approach ambient or atmospheric pressure, which isreferred to herein as “zero pressure.” The use of zero pressurecontrasts with traditional therapeutic CPAP, which maintains atherapeutic level of pressure at all times when therapy for obstructivesleep apnea is needed.

A sub-therapeutic control mode allows very low mask pressures at timeswhen therapy is not needed, desired or intended. The very low maskpressures make using the system more pleasant for the user by removingunnecessary or undesired pressure wherever possible while reducing thelikelihood of compromising other functions of the system (e.g., externalventing to reduce the likelihood of CO2 rebreathing). Because ofincreased comfort produced by reduced perceived pressure whentherapeutic airway support is not needed or not desired, thesub-therapeutic control mode is believed to encourage increasedcompliance, which will extend the time the user wears the system andreceives therapeutic CPAP treatment.

A limiting factor in the implementation of sub-therapeutic gas deliverywith existing CPAP machines is that substantially all systems currentlyused with CPAP machines rely on non-zero mask and circuit pressure toforce air through a “leak port” throughout the respiratory cycle. Theair forced out through the leak port provides venting of exhaled carbondioxide, particularly during exhalation, and reduces the likelihood ofrebreathing of exhaled gas during the next inspiration. When the maskand circuit pressure falls below a certain low level (e.g., generallyaround 2 cm H2O to 5 cm H2O depending upon the size of the leak port),venting through a fixed size leak port becomes generally ineffective.

Two types of valves that can be used in the system that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention are “non-rebreathing” valves and “exhalationvalves.” Each of the two types of valves creates a second port throughwhich exhaled gas can be directed to reduce the likelihood ofrebreathing. Non-rebreathing valves generally are passively opened whenthe relevant pressure is substantially zero or zero (e.g., when a gassupply apparatus has stopped functioning) or when flow reverses within acircuit. Exhalation valves also can be used in non-CPAP circuits andtypically trigger from shut to open with rises in pressure duringexhalation. Exhalation valves are often driven by an external triggeringmechanism that detects expiration; however, when used during CPAP, theexhalation valves cannot be dependent on pressure at the valve alonebecause the pressure is high in both therapeutic CPAP and duringexhalation. In addition, the valve must be actively triggered or drivenby an outside controller. In some embodiments, the system can beimplemented with specifically adapted valves having characteristicsdescribed later in this specification.

Some implementations of the sub-therapeutic mode utilize an externaldecision about which mode of the valve is active. At a predeterminedpoint, which could be predicated on the desired CPAP pressure or on thestate of arousal of a user, the controller adjusts the characteristicsof the flow and pressure in the circuit to trigger an increase in theleak out of the circuit, such as, for example but without limitation,opening an additional port or otherwise creating an increase in leakageflow. In the therapeutic CPAP mode, the controller delivers gases at aflow and pressure such that the valve minimizes the size of the leak(e.g., by closing the additional port). Preferably, the change in valvebehaviour occurs generally as a passive response of the valve but inresponse to some signal generated by an algorithm controlling CPAPdelivery.

Preferably, the transition from the sub-therapeutic mode to theconventional therapy mode of operation (i.e., CPAP) happens in asubstantially “smooth” fashion and does not significantly oscillate withrespiratory swings. Thus, the mode change may be largely undetected orminimally intrusive to the user. One aspect of making the transitiongenerally transparent to the user is minimizing the change in systemconditions (e.g., pressure and flow) that activates the change in modeof operation of the valve while preserving the stability of the valvemode.

Certain features, aspects and advantages of the present invention relateto a valve with two modes. Certain features, aspects and advantages ofthe present invention relate to activating control of the valve modethrough changes in the behaviour of the CPAP gas supply without otherexternal control signals to the valve. Preferably, despite minimalchange in pressure but at a desired time, the valve switches between an“open” state, a state with minimal pressure in the circuit and low butsignificant flow to the user, and a “closed” state, a state withpressure that can be raised to therapeutic levels, and the transitionoccurs with little or no change in the system conditions perceived bythe user. In other words, the “open” state refers to the interior of thecircuit being open to ambient surroundings through the valve while the“closed” state refers to a state where the valve does not allow the samesubstantial flow between inside the circuit and ambient through thevalve. However, some flow between inside the circuit and ambient may beprovided for in the closed state. For example, the valve may incorporatea bias flow vent to provide suitable leak during therapy.

With reference to FIG. 2, the system generally comprises a gas supplydevice 200, a user interface 204, a supply conduit or tube 202 forconnecting between the supply device 200 and the user interface 204 anda flow diversion device 250. The flow diversion device preferably islocated at or generally adjacent to the user interface 204.

The flow diversion device 250 can operate in at least two modes. In someconfigurations, the flow diversion device 250 operates in only twomodes. In a first mode, the gases space inside the user interface 204 issubstantially open or open to ambient surroundings through the flowdiversion device 250. In a second mode, the flow diversion device 250allows the user to receive a gases flow at a therapeutic treatmentpressure from the gases supply device 200.

Preferably, the flow diversion device 250 comprises a type of valve inwhich the valve 250 is in the first mode or condition at low pressure orflow conditions (i.e., sub-therapeutic supply conditions). In thiscondition, the interior of the user interface 204 is substantially opento ambient surroundings through the valve 250. In the second mode orcondition, the valve 250 is closed and the gases space inside the userinterface 204 is significantly less open to ambient surroundings throughthe valve 250.

Typically, the gases space inside the user interface 204 may beconnected at all times with the ambient environment through a vent 206,such as a bias flow vent or other controlled leak port. For example, thevent 206 is illustrated in FIG. 2 on the user interface 204. In someconfigurations, the vent 206 may be part of the flow diversion device250 itself.

Preferably, the flow path to ambient surroundings through the flowdiversion device 250, with the valve in the first mode, is a path ofmuch lower resistance than the flow path through the controlled leakprovided through the vent 206. Thus, with the flow diversion device 250in the first mode, the flow path between the gases supply device 200 andthe gases space inside the user interface 204 is somewhat restricted butis not closed while a comparatively open flow path is provided betweenthe gases space inside the user interface 204 and the surroundingambient conditions through the flow diversion device 250. In the secondmode, there is comparatively little or no flow between the gases spaceinside the user interface 204 and the surrounding ambient conditionsthrough the flow diversion device 250 while the flow diversion device250 presents a comparatively low flow restriction between the gasesspace inside the user interface 204 and the gases supply device 200.

Preferably, the control of the gases supply device 200 and thearrangement of the flow diversion device 250 (e.g., the valve) areadapted so that, in a period of transition in either direction betweendelivery of pressure support to the user and delivery of asub-therapeutic supply to the user, user breathing does not triggerrepeated cycling between the first mode and the second mode of the flowdiversion device 250. Accordingly, the valve 250 does not flutter to anysignificant degree at this transition.

Preferably, the flow diversion device 250 switches from the first modeto the second mode and from the second mode to the first mode accordingto the prevailing flow and pressure conditions. Typically, these flowand pressure conditions are generated by the gases supply device 200 anduser breathing. Thus, the gases supply device 200 provides a basecondition (e.g., flow and/or pressure) and the user breathingsuperimposes a transient variation in flow and/or pressure as the userinhalation and exhalation flow is superimposed on the flow from the gassupply device 200.

The flow diversion device 250 preferably has no means of control otherthan the prevailing flow and/or pressure conditions acting on the valve250 and an associated valve member. The valve 250 is not activelycontrolled except by the flow generator 200 varying the prevailingpressure and/or flow conditions.

When the system gradually moves between a sub-therapeutic pressure and atherapeutic support pressure in the gases supply, the flow diversiondevice 250 closes to be in the second mode. Similarly, in moving from atherapeutic support pressure to a sub-therapeutic level, the flowdiversion device 250 opens to be in the first mode.

The transition can be unstable for regular pressure or speed controlflow generators. In particular, as the conditions reach a level at whichthe valve 250 will move from the first mode to the second mode, thefluctuation in conditions caused by user breathing can lead to the valve250 opening and closing with each user breath. A similar effect can benoted where the pressure support is decreasing toward thesub-therapeutic level and approaches the transition conditions for theflow diversion device 250.

Accordingly, the flow diversion device 250 in the illustrated systemswitches from the first mode (i.e., the open mode) to the second mode(i.e., the closed mode) at a first set of conditions, and from thesecond mode (i.e., the closed mode) to the first mode (i.e., the openmode) under a second set of conditions. The first set of conditions isrelatively higher than the second set of conditions. Accordingly, withthe average pressure and/or flow increasing, when the flow diversiondevice 250 switches from the first mode to the second mode, the minimumpressure and/or flow is already above the pressure and/or flow at whichit would switch from the second mode to the first mode. Similarly, whenthe average pressure and/or flow is decreasing, once the flow diversiondevice 250 switches from the second mode to the first mode, the minimumpressure and/or flow is already below the pressure and/or flow at whichit would switch from the first mode to the second mode.

Preferably, the difference in the level of the conditions is greaterthan the fluctuation in the conditions resulting merely from userbreathing. The fluctuation depends on system conditions. For example,pressure fluctuation in the region of the valve 250 depends onresistance to flow exiting the system. With the flow diversion device250 open, the interior of the user interface 204 and flow diversiondevice 250 are more openly connected to the surrounding ambientconditions and the fluctuating pressure creates a smaller pressure swingthan with the flow diversion device 250 closed. Furthermore, with alarge bias vent 206, the pressure swing caused by breathing is reduced.

Certain characteristics of the gas supply apparatus 200 can exacerbatethe pressure swing from user breathing. For example, a pressure feedbackcontrol operating to control the output of the flow generator canexaggerate the fluctuation in flow.

The valve 250 is biased toward the open condition. In thesub-therapeutic mode, the delivered supply is intended to allow thevalve 250 to remain in the open condition. The pressure feedback controlcan have an adverse impact as the delivered supply approaches thecondition that, in a steady state, would trigger the valve 250 to switchto the closed condition. In particular, within each breath cycle, thepressure control increases the output of the flow generator duringinhalation relative to exhalation. This brings the flow passing thevalve 250 to a critical point, thereby priming the valve 250 forclosure. During the next expiration by the user, pressure rapidlyincreases in the circuit 202 and the “primed” or partially closed valve250 now fully closes.

In some embodiments, the gas supply device 200 operates with a controlmethod that reduces the occurrence of valve instability (i.e., valveflutter) caused by the fluctuation of the flow from user breathing. Inparticular, the control method for the gas supply device 200, at leastas the supply condition approaches the transition conditions between thefirst mode and the second mode, is adapted to not significantlyexacerbate, and preferably to alleviate, fluctuation in the particularsystem conditions that cause switching of the valve 250. For example,the valve 250, which will be described later, is sensitive to flow. Inparticular, the valve 250 is sensitive to flow from the gas supplydevice 200 to the user interface 204, to flow to ambient through thevalve 250, or both. As the supply conditions approach levels where thevalve 250 might be unstable, the control method controls the output ofthe gas supply device 200 according to an assessed average supply flowand a desired average flow. For example, the control of the gas supply200 can implement a feedback control based upon average gases flow.Preferably, during this period, the method does not include a feedbackcontrol based upon pressure. This stabilises the flow, or at leastremoves a destabilising influence on the flow delivered by the flowgenerator or gas supply device 200. The flow still fluctuates with userbreathing, but the controller does not take steps that exaggerate thisfluctuation.

Accordingly, in some embodiments, the control results in a substantiallyconstant low flow generator speed and does not respond to user breathingby changing the speed of the flow generator during the breathing cycle.Because the flow is low and does not increase as much when the userinspires as it would for a pressure feedback control, the valve 250 isnot “primed” for closure, and thus does not close during expiration.

In therapeutic CPAP mode (e.g., at circuit pressures above a lowthreshold of about 2-3 cm H20), the controller provides feedback to theflow generator to maintain a “pressure control.” During inspiration,this causes an increase in the delivered flow in order to maintainpressure, which brings the flow passing the valve 250 to a level thatprimes the valve 250 for closure. During the next expiration by theuser, pressure rapidly increases in the circuit 202 and the “primed” orpartially closed valve 250 now fully closes. Furthermore, the valve 250is subsequently kept closed by the now continuous positive pressure(e.g., CPAP).

In effect, the above described two modes result from tuning the CPAPflow generator response to the oscillatory nature of a user's breathingand from using the resulting interaction of the pressure and flow toswitch the valve mode without actually actively interacting with thevalve 250 with a separate controller.

A benefit of this tuning between pressure control and flow control ofthe gases supply device 200 and user breathing is that, when the flowgenerator is switched between modes, the valve state can be controlledwith minimal change in either pressure or flow alone to the user at thetime of the switch.

When arranged and configured in accordance with certain features,aspects and advantages of the present invention, the system provides asub-therapeutic pressure at the beginning of the session or at timeswhen the apparatus considers the user to be awake. As used herein,sub-therapeutic pressures include pressures below about 4 cm H2O,preferably below about 3 cm H2O and more preferably pressures belowabout 1.5 cm H2O and most preferably pressures about 1 cm H2O. Thesub-therapeutic mode may be selectable by a user, may be selectable byan overall control algorithm of the apparatus, or may be an automaticfunction at the beginning of every session of use of the apparatus. Oncethe user is asleep, or after an initial time-set period ofsub-therapeutic delivery, the apparatus transitions and delivers atherapeutic pressure.

Preferably, sub-therapeutic pressure is provided to the user inconjunction with monitoring the flow delivered to the user. Thecontroller of the apparatus monitors the flow delivered to the user andadjusts control of the flow generator to reduce the likelihood oreliminate flow rates that may be insufficient to provide proper flushingof the user interface. For example, the control may reduce thelikelihood of the average flow rate falling below about 10 litres perminute, preferably reduces the likelihood of the average flow ratefalling below about 12 litres per minute, most preferably reduces thelikelihood of the average flow rate falling below about 15 litres perminute.

For a given user interface, a particular flow rate may be consideredsufficient to provide appropriate flushing. Across most user interfacespresently available, an average flow rate of about 15 litres per minuteis thought to be sufficient. Whatever the chosen flow rate, while in thesub-therapeutic mode, the apparatus preferably adjusts operation of theflow generator to maintain an average flow rate close to the chosen flowrate. For example, the controller may maintain the average flow withinabout 5 litres per minute of this amount, or most preferably withinabout 2 litres per minute of this amount.

By way of example, the controller of the apparatus may control the flowgenerator by controlling the power input to the flow generator. In thiscase, in the sub-therapeutic mode, the controller may decrease powerinput to the flow generator when the measured average flow exceeds thedesired flow range and may increase flow generator power when theaverage flow is below the desired range.

Alternatively or in addition, the controller may control some otherparameter of the flow generator, such as, for example but withoutlimitation, motor speed. In such a case, the controller may command anincrease in motor speed if the flow is below the desired range andcommand a decrease in motor speed if the flow is above the desiredrange.

Alternatively or in addition, the flow generator may include a pressuresource and a pressure regulator. In such a case, the controller mayreduce the set pressure of the pressure regulator when the measured flowis above the desired range and may increase the set pressure of thepressure regulator when the flow is below the desired range.

Advantageously, the apparatus may operate in the sub-therapeuticdelivery mode during periods where the user is awake but in atherapeutic delivery mode when the user is asleep.

Accordingly, the controller may provide an initial period of operationin the sub-therapeutic mode during each session of use. This feature mayalso be used in an apparatus that includes functions for determiningthat a user is awake during periods within the session. For example, theFisher & Paykel Healthcare HC250 device with “Sensawake” functiondetermines instances of user arousal and reduces the delivered pressureto a pre-set awake pressure once it determines that the user may beawake. By implementing the above-described controls in such a device,the device could, after reaching the awake pressure, enter thesub-therapeutic mode.

In the sub-therapeutic mode, the control aims to maintain asubstantially steady flow at a flow level that is selected to besufficient to maintain appropriate flushing of the user interface 204.As used herein, substantially steady flow means that the average flowover a period of multiple breaths (e.g., about 20 breaths) remainssubstantially constant or within a limited range (e.g., a range of up toabout 5 litres per minute) despite changing system conditions. Changingsystem conditions includes, for example but without limitation, changingleak conditions due to changes in the efficiency of sealing of the userinterface. By way of clarification and comparison, changes in systemconditions that would see an increase in flow under a constant pressurecontrolled system of greater than about 5 litres per minute areresponded to with a substantially steady flow in the sub-therapeuticmode.

In the therapeutic mode, the controller delivers a substantially steadypressure. This may include a pressure feedback control, or be the resultof a flow generator with a steady pressure output for a given operatingspeed. Like substantially steady flow, substantially steady pressurerefers to the average pressure over multiple breaths.

One non-limiting example control method that is arranged and configuredin accordance with certain features, aspects and advantages of thepresent invention is illustrated in FIG. 1. The illustrated controlmethod may be incorporated into an apparatus that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention. The illustrated method for implementing thesub-therapeutic mode commences at 100 and may be triggered by aconscious user choice, such as, for example but without limitation, byselecting a control mode using the electrical user control interface. Insome embodiments, the mode may be an initial starting mode for theapparatus or may be commenced by the apparatus according to a widercontrol strategy.

After starting, a control command issues to the flow generator to causethe flow generator to operate at an initial level. See 102. For examplebut without limitation, the controller can supply a command motor speedas an input to the flow generator and a motor of the flow generator canbe speed-controlled to the command motor speed. In some applications,the apparatus may provide one or more of one or more command pressurevalues, one or more command flow values or one or more motor powerinputs as input parameters. Preferably, the initial command inputparameter for the flow generator is at a level that would usuallyprovide a sub-therapeutic pressure between about 0.2 cm H2O and 2 cm H2Owith a user interface correctly fitted. In the illustrated example, themotor speed is set to about 4000 rpm.

An evaluation then is made regarding whether the user is asleep. See104. Preferably, the controller maintains a value representing thecontroller's belief that the user is asleep or awake. This value may bea probability assessed by the controller of whether the user is asleepor awake. The value can be assessed against criteria to decide whetherto proceed on the basis that the user is asleep or to proceed on thebasis that the user is awake.

The value may be maintained by, for example but without limitation,assessing recent breathing patterns of the user, assessing recenthistory of apneaic events and/or obstructed breathing of the user. Thismay be examined over a time period, such as, for example but withoutlimitation, the preceding few minutes, ten minutes or other similar timeperiod. Any suitable methods of making a determination that the user isasleep or is awake can be used. Some suitable methods are described inother patent publications, for example U.S. Pat. No. 6,988,994 and US2008/0092894, which are hereby incorporated by reference in theirentirety.

The “asleep” assessments, and the maintenance of a sleeping value, maybe made according to a separate control program running in parallel withthe control program described with reference to FIG. 1. The separatecontrol programs may be generally separate subroutine routines that maybe executed sequentially in a given execution cycle but also may operatein parallel. If a separate control program is used, the control programof FIG. 1 will determine whether the user is asleep or awake based on aninput parameter maintained or output by the other control program.

If the program determines that the user is asleep, then a therapeuticpressure is applied. See 106. The application of therapeutic pressureapplication may begin, for example, by immediately proceeding to apredetermined starting point pressure (e.g., about 3 or 4 cm H2O orgreater) for therapy. This pressure may be a preset of the device or maybe a variable pressure set by a physician. In some configurations, themethod may proceed directly to a full treatment pressure, for example, atreatment pressure prescribed by a physician and preconfigured in thedevice. In some configurations, the control method may proceed to anautomatic titrating mode that commences at a starting therapeuticpressure and that adjusts the supply pressure according to breathingevents, such as apneas, hypopneas, flow obstructions, and periods ofnormal breathing.

In the therapeutic mode, the control method preferably seeks to maintaina substantially steady pressure. For example, the controller may controlthe flow generator based on input from a pressure sensor that sensespressure in the user interface 204 using feedback from the pressuresensor to control the speed of, or power input to, the flow generator,or to control the input parameter of a pressure regulator. The pressurein the patent interface 204 can be sensed in any suitable manner. Forexample, the pressure can be sensed either by a sensor that ispositioned directly in the user interface 204 or by a sensor thatinterfaces with a part of the flow path to the user interface 204 thatis downstream of the flow generator.

In some embodiments, the substantially steady pressure can be generatedusing a fan having a substantially constant pressure output for a givenfan speed across a wide range of flow or from a pressure regulator, suchas a self-regulating pressure regulator for example but withoutlimitation, that may, for example but without limitation, use amechanically operative feedback control to adjust the pressure outputaccording to a particular input parameter.

The therapeutic mode (e.g., positive pressure, CPAP or autotitrating)may proceed according to any suitable treatment program and/or method.Control of the particular applied pressure in these methods may be by aseparate control program or routine running in parallel or otherwise inconjunction with the control program described with reference to FIG. 1.

With reference again to FIG. 1, the illustrated control method beginslooping to determine when a user awakens so that the machine can respondto the awakening of the user. See 108. For example, the control loopdepends upon the output of the separate control loop that determines ona continuous basis an awakened state of the user.

As shown at 110, if the user is still asleep, the method continues toapply the therapeutic treatment pressure. See 106. The control loop 106,108, 110 continues until it is determined that the user is awake. If itis determined that the user is awake, the method commences thesub-therapeutic mode. For example but without limitation, thesub-therapeutic mode can be commenced by changing the input parameter tothe flow generator so that the flow generator provides gases at asub-therapeutic pressure. See 102.

Once again, the method determines whether the user is awake. See 104. Ifthe user is awake, the method proceeds to measure the flow. See 118. At118, 120, 124, the measure of the flow is compared against a preferredflow range and, at 124, 128, the input parameter sent to the flowgenerator is adjusted accordingly. Preferably, the method checks (see118) an assessed flow against a lower flow value. For example, themethod checks whether the recent average flow (e.g., the average flowover the preceding 5 breaths, 10 breaths, 10 seconds, 30 seconds or asimilar period) is less than a lower threshold (e.g., about 15 L/min).

The lower threshold may be a fixed predetermined value. For example, thevalue may be chosen to be suitable for all suitable user interfaces. Insome embodiments, the lower threshold value may be a settable value, forexample, so that it can be set according to a particular user interfaceused by the user. In some embodiments, the lower threshold value may betaken from a table of values based on a determined identity of the userinterface or might be assessed for a particular interface in a test modeperformed by the apparatus. In the simplest case, a fixed preset flowvalue, such as a lower limit flow value of about 15 litres per minute,is thought sufficient to provide a significant improvement in comfortover prior art apparatus without compromising safety.

If the assessed average flow is less than the lower threshold level, thecontrol method adjusts the input parameter to the flow generator toincrease the output of the flow generator. For example, the controllermay increase a demand motor speed. See 124.

An additional check may be provided after determining that the averageflow is below the lower control limit. See 122. The additional checkdetermines whether the pressure has reached a therapeutic pressurelevel. While shown occurring after the lower control limit check (see118), the pressure level check can occur at any suitable time. Forexample, in the illustrated method, the additional check may beconducted between the lower threshold level check and the outputincrease. See 122, 118, 124. Preferably, the method checks an assessedpressure in the user supply against a pressure threshold, for examplebut without limitation, 4 cm H2O. See 122. Where the flow is assessedbelow the lower limit at 118 and the pressure is assessed above thethreshold at 122, the method preferably proceeds to leave thesub-therapeutic mode and switch control to the therapeutic mode, asdiscussed above with reference to 106.

The control method may also set a fault condition, for example at 126.The controller may provide an indication of the fault condition as analert on the electrical user control interface of the device or recordthe fault condition in a session data log maintained by the device forlater review by the user, physician or other interested party.

Where the control method increases the flow generator output at 124,this is, for example, by increasing the demand parameter for the flowgenerator. The increase may be a fixed predetermined incrementalincrease, an incremental increase that varies according to the presentvalue of the parameter, or an incremental increase that varies accordingto the difference between the present value of the average flow and thedesired flow range. For example but without limitation, the new inputparameter (e.g., the new motor speed in a control motor speedembodiment) may be a function of the present motor speed, the presentaverage flow value and a desired average flow value.

Alternatively, if the average flow value is above the minimum rangevalue (see 118), the control method checks the average flow valueagainst an upper flow value threshold for the range. See 120.Preferably, to maintain a low sub-therapeutic pressure, the flow rangebetween the minimum value and maximum value is kept to a minimum. Forexample, the flow range may be about 5 litres per minute or less,preferably about 3 litres per minute or less, and most preferably about2 litres per minute or less.

Alternatively, both upward and downward adjustment of the controlparameter for the flow generator can be made based on a single desiredaverage flow value. This is particularly suitable if an adjustmentincrement for the control parameter is a function of the differencebetween the present average flow value and the desired average flowvalue. In this method, the check against the upper flow value threshold(see 120) can be removed with the method proceeding directly from 118 to128 in the case where the average flow value is not less than thedesired flow value. This arrangement will lead to frequent adjustment ofthe motor input parameter, but if the frequent adjustments are small,they may not be significant. Similarly, a configuration can be used todoes not have a lower flow threshold being used.

If the average flow is determined to be above the preferred range at 120(or at 118 according to the modified method discussed above), then at128 the control method decreases the input parameter to the flowgenerator. For example, the decrease may be a predetermined increment,or an increment variable according to the present average flow, thepresent value of the input parameter or the difference between thepresent average flow and the desired average flow range. The method thenreturns to 104. The method set forth at 104, 118, 124, 120 and 128broadly constitute a feedback control controlling the output of the flowgenerator according to a desired flow rate (or desired flow rate range)and based on an assessed average flow rate value.

FIGS. 3A and 3B illustrate the effect of a control operating inaccordance with certain features, aspects and advantages of the presentinvention. These plots are only intended to be representative and havebeen simplified accordingly. Section A of FIG. 3A shows normal breathingat the beginning of a session. The pressure is low (e.g., approximately0 cm H2O) however the flow is averaging less than about 15 l/min.

Section B of FIG. 3A shows the device responding to the low flow rate inSection A, which results in increased flow generator speed (e.g., 118,124 in FIG. 1), thereby causing the flow and pressure to rise.

Section C of FIG. 3A shows a leak being introduced (e.g., a mask leakoccurs) and the level of flow increasing accordingly. The pressure dropsslightly due to the leak.

Section D of FIG. 3A shows the algorithm responding to the increasedlevel of flow by reducing the speed of the flow generator until the flowis again averaging approximately 15 l/min (e.g., 120, 128 in FIG. 1).The drop in speed further reduces the pressure.

Section E of FIG. 3B shows normal breathing.

Section F of FIG. 3B shows a user having an apnoea. The apnoea is shownby the flattening of the flow signal.

Section G of FIG. 3B shows that, in response to the event in Section Fof FIG. 3B, the device raises the pressure and normal breathing resumes(e.g., 104, 106 in FIG. 1).

The chaotic flow signal at the end of Section G indicates that the userhas awoken and, at Section H, the pressure is reduced accordingly untilthe approximately 15 l/min average flow is maintained again (e.g., 108,102 in FIG. 1).

With reference again to FIG. 2, FIG. 2 presents a block diagramillustrating an embodiment of a breathing gases supply system that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention. The full system includes the gassupply device 200, which is an apparatus for delivering a supply ofbreathing gases, the supply conduit 202 and the user interface 204. Asdiscussed above, the flow diversion device 250 can be located at, on oradjacent the user interface 204. Preferably, the flow diversion device250 is in one of these locations because it allows venting to theatmosphere under certain operating conditions, which limits carbondioxide rebreathing and provides oxygen. The supply conduit 202 extendsfrom an outlet of the gases supply device 200 to the user interface 204.

The user interface preferably includes the bias flow vent 206 thatallows a controlled leak from the user interface 204. The controlledleak allows the inside of the user interface 204 to be continuouslyflushed by fresh gases supplied by the supply device 200. The userinterface 204 may comprise any of the many types of typical userinterface for PAP delivery, including but not limited to, for examplebut without limitation, nasal masks, full face masks, oral masks, oralinterfaces, nasal pillows, nasal seals or nasal cannulas.

The vent 206 may be located directly on the user interface 204, the vent206 may be located adjacent the user interface 204 on a connectorbetween the user interface 204 and the supply tube 202, or the vent 206may be located through the wall of the supply tube 202 at a locationclose to the user interface 204, for example but without limitation.

The illustrated supply apparatus 200 includes a flow generator, whichcan comprise a fan 210 driven by an electric motor 212. Air is drawnthrough an inlet 214 in the housing of the apparatus by the fan 210.Pressurised air leaves the fan 210 and is supplied to the user throughthe supply conduit 202, for example. In some embodiments, controllableflow generators may draw on a source of high pressure gas and regulate aflow of gas from the high pressure source.

The apparatus 200 may include a humidifier 216. In some embodiments, thehumidifier 216 comprises a pass-over humidifier where air passingthrough a humidifier chamber picks up a quantity of water vapour from awater supply contained in a reservoir 218. The water reservoir 218 maybe heated by a heater 220. The humidifier 216 may be integrated withinthe same housing as the flow generator 210 or may be a separatecomponent that can be used as an option.

The heater 220 and the motor 212 are supplied with power from a powersupply 222. The amount of power to the motor 212 and the amount of powerto the heater 220 can be controlled by outputs of a controller 224. Thecontroller 224 is also supplied with power from the power supply 222.The controller 224 receives input from an electrical user controlinterface 226, for example but without limitation. The controller 224preferably includes an embedded microcomputer with stored controlprograms or the like.

The controller 224 is also provided with an interface 228 that is usedto connect with an external data source. For example but withoutlimitation, the external data source may be a communication interface,such as a modem, or may be an interface to an external memory, such as asmart card, disk drive, flash memory or the like. For generic use, theinterface 228 may be any suitable data communication port that isarranged and configured in accordance with any of the many availablestandards (e.g., a universal serial bus (USB) port). The interface 228can be used for connecting a wide range of peripheral devices. In someconfigurations, the interface 228 can be replaced by or augmented with awireless communication device (e.g., Bluetooth, wifi, etc.).

The controller 224 preferably includes interfaces for receiving inputfrom the electrical user control interface 226 and for receiving inputfrom one or more sensors. The sensors can include a flow sensor 230 anda pressure sensor 232. The pressure sensor 232 can be positioneddownstream of the fan 210. The flow sensor 230 can be positionedupstream or downstream of the fan 210.

The apparatus preferably is configured to perform control methods in theform of control programs executable by a microcomputer of the controller224, for example but without limitation. In some embodiments, thecontroller 224 may comprise a fixed electronic circuit implementingcontrol programs, a programmed logic circuit (e.g., an FPGA)implementing control programs or the like. Any suitable Electroniccircuits and logic circuits implementing the control program may beused. In fact, all of the methods and processes described herein may beembodied in, and fully automated via, software code modules executed byone or more general purpose computers or processors. The code modulesmay be stored in any type of computer-readable medium or other computerstorage device. Some or all of the methods may be embodied inspecialized computer hardware. In addition, the components referred toherein may be implemented in hardware, software, firmware, or acombination thereof.

The illustrated apparatus, which preferably operates according to thecontrol methods described herein, provides a sub-therapeutic mode ofoperation that is applied to the user while the user is awake. Breathingat this lower pressure may be less arduous than at the low therapeuticpressures applied at the commencement of therapy by other devices. Thismay be more comfortable and more pleasant for the end user, therebyimproving therapy acceptance and compliance. At the same time, a minimumflow through the supply conduit 202 is provided to supply an adequateflow of fresh breathing gases to the interface 204 to flush the userinterface 204 and reduce the likelihood of user re-breathing.

As described above, upon the detection of sleep, or a breathing disorderevent, the apparatus will increase the delivered pressure to apredetermined or automatically determined therapeutic level at acomfortable and tolerable rate. When sleep or a breathing disorder eventoccurs, the user can be assumed to be asleep. Accordingly, the usershould not be aware of or consciously experience the required highertherapeutic pressures, again thereby hopefully improving compliance.

Preferably, if the user wakes during the sleep session, the apparatuswill revert to the sub-therapeutic state. The now conscious user willnot experience, or will only experience for a limited time, the highertherapeutic pressures that are supplied while they are asleep becausethe apparatus returns to the sub-therapeutic state. This should alsoincrease user compliance, particularly in the later stages of a sleepsession, where otherwise the user may remove and cast aside the userinterface before trying to return to sleep.

The method as described may be adapted by further variations. A few ofthese variations have been described above and several more will bedescribed below. This is not an exhaustive summary and many furthervariations and alternatives are possible without departing from thescope of certain features, aspects and advantages of the presentinvention.

According to one variation, the apparatus may monitor one or more of theflow, the pressure, or other parameters that may indicate userrespiratory rate. From the user respiratory rate, the controller maydetermine increased respiratory rate or increased breath volume. In thepresence of increased respiratory rate or breath volume, or both, thecontroller 224 may increase the desired flow level in thesub-therapeutic mode. Increased respiratory rate or increased breathvolume may be indicative of carbon dioxide rebreathing. Increasing thedesired flow level in the sub-therapeutic mode may adapt thesub-therapeutic mode flow level to account for prevailing systemconditions. The controller 224 may further filter this responseaccording to the present user sleep state, which may help to reduce thelikelihood of false positives due to dreaming, mask leaks and the like.

According to a further variation, one or more routines may be providedto check for occurrences of negative pressure in the user interface 204during the sub-therapeutic supply mode. For example, the control programof the controller 224 may measure, derive or calculate a pressure in themask or interface 204 on a continuous basis, or at least at a point intime or points in time during user inhalation. If the mask or interfacepressure drops below a predetermined threshold (e.g., about 0 cm H2O orslightly below about 0 cm H20) during user inhalation, then the controlprogram adapts the delivered therapy in an effort to reduce or eliminatethese subzero pressures. These negative pressures may otherwise beexperienced by the user as an undesirable feeling of being starved ofair. The control program may apply the adaption instantaneously (e.g.,applied within a breath cycle) or over a longer time period (e.g.,adjusting an inhalation boost parameter periodically).

The controller 224 may obtain the pressure in the interface 204 byproviding a sensor at the interface 204 to receive direct measurementsof the internal pressure at the user interface. In some embodiments, thecontroller 224 may predict the pressure at the interface 204 from ameasurement of the pressure of the delivered flow leaving the flowgenerator 210 (e.g., before or after the humidifier 216) and a predictedpressure drop between the location of the measurement and the interface204 (e.g., across the length of the supply conduit). The control programcan predict the pressure drop on the basis of the instantaneous flowalong the conduit 202, for example. The control program can assume theconduit 202 has a certain flow resistance or can calculate theresistance of the conduit 202 or other assembly of components byimplementing a pre-therapy test comparing delivered pressure and flowwith no user interface connected to the conduit. The control program mayimplement any suitable method.

The control program may adapt the sub-therapeutic supply in a number ofways. One option would be to boost the target average flow. However,boosting the target average flow may boost the peak pressures duringuser exhalation and will boost the overall average pressure, therebyreducing some of the comfort advantages intended.

In some configurations, the controller can boost the supplied flow onuser inhalation, for example, by increasing the output of the flowgenerator at the start of inhalation and subsequently reducing theoutput of the flow generator back to a lower level for exhalation. Thecontrol program may monitor user respiration to determine the start andend of inhalation by monitoring the variation in delivered flow orpressure on a breath-by-breath basis. While the average flow overmultiple breaths is maintained substantially constant, the flow variesin an essentially sinusoidal manner in time with the user breathing. Theflow is higher during inhalation than during exhalation. The controlprogram can determine the inhalation phase from this variation.

According to another variation, the control program (e.g., the controlprogram run by the controller) may provide a settable parameterproviding for a boosted inhalation flow. For example, a settableparameter may be provided on a scale. A value of 0 indicates no boost tothe input parameter for the flow generator during inhalation relative toexhalation. A progressively higher value indicates a progressivelyhigher boost to the input parameter of the flow generator used duringinhalation relative to exhalation. The user or the user's physiciancould set the parameter according to measurement, according to aqualitative assessment of total breathing volume of the user, oraccording to reported instances of breathlessness during thesub-therapeutic supply phase.

The controller 224, while implementing the sub-therapeutic phase, maycontrol a baseline input parameter to the flow generator 210 accordingto the average delivered flow and, during periods of inhalation orperiods of exhalation, may control the input parameter to the flowgenerator 210 according to a combination of the baseline parameter andthe settable inhalation boost. According to this, the baseline could beapplied during inhalation or exhalation. If the baseline is appliedduring exhalation, then the inhalation parameter is a boost above thebaseline. Where the baseline is applied during inhalation, theexhalation pressure is a reduction below the baseline according to theset parameter. By boosting the flow (i.e., boosting beyond the normalfluctuation provided by the user breathing alone) during inhalationrelative to exhalation, these variations reduce the likelihood of anyfeeling of starvation at the interface 204.

According to a further variation, the control method may include controlof humidification of the breathing gases (e.g., by varying a power inputto a humidification heater 220) such that humidification delivery in thesub-therapeutic mode is controlled independently of humidificationdelivery in therapeutic modes. For example, in the sub-therapeutic mode,the controller may reduce or disable humidification (e.g., by reducingor turning off power to the humidification heater 220).

According to a further variation, the apparatus may include a userselectable, or automatically initiated, test sequence. According to thetest sequence, the control program causes the flow generator 210, 212 todeliver a controlled therapeutic pressure for a period of time. It isintended that the user will not consciously experience high pressures atthe interface 204. The test sequence will provide an opportunity for theuser to ensure that the mask is fitted correctly. The control programmay provide for a test sequence selectable by a user at the electronicuser control interface, or may provide for the test sequence toautomatically commence at the beginning of the session, or both. Thetest sequence may provide for a pressure delivery at a preset minimumtherapeutic pressure, a preset maximum therapeutic pressure, a presettest pressure, or another pressure selected according to previous use ofthe device (e.g., a 95th percentile pressure established from previoussessions).

In some configurations of the apparatus, such as described withreference to FIG. 2, the apparatus includes the flow sensor 230 and thepressure sensor 232. Each sensor, 230, 232 may be of any suitable type.For example, the flow sensor 230 may be a differential pressure sensoroperating in conjunction with a flow restriction. In that case, parts ofthe differential pressure sensor may double as the pressure sensor. Insome applications, an assessed pressure may be derived independently bya discreet pressure sensor. In some applications, the delivered pressuremay be inferred from blower speed, or calculated from a sensed flow andblower speed, for example but without limitation. An assessment of thedelivered pressure may also account for an estimated pressure dropbetween the PAP apparatus and the user, for example, by accounting for apressure drop along the conduit 202 according to a measured flow. Inaddition, where the pressure sensor 232 is present, flow can be inferredfrom blower speed and the output of a pressure sensor rather than usinga separate flow sensor. Otherwise, any suitable flow sensor can be used.

FIG. 9A to FIG. 9C illustrate a flow diversion device 900 that can beused in an implementation of a system that is arranged and configured inaccordance with certain features, aspects and advantages of the presentinvention. The flow diversion device 900 can be arranged as a connectorfor simplicity of assembly with other pre-existing components.

The illustrated flow diversion device 900 includes an inlet portion 902and an outlet portion 904. In some embodiments, the inlet portion 902comprises an inlet connector portion 902 and the outlet portion 904comprises an outlet connector portion 904. The inlet connector portion902 includes an external tapered connecting surface. The externaltapered connecting surface can be a standard taper. The outlet connectorportion 904 includes an internal tapered connecting surface. Theinternal tapered connecting surface is used to secure a swivelconnector, for example but without limitation. Other configurations arepossible.

A flow passage or bore is provided through a body of the flow diversiondevice 900 from the inlet end of the inlet portion 902 to the outlet endof the outlet portion 904. A central portion 906 comprises a flow port908 extending through a wall of the flow diversion device 900. The flowpath through the flow diversion device 900 can communicate with theambient surroundings through the port 908.

A flexible valve member 910 extends into the flow path at a locationbetween the inlet to the inlet portion 902 and the port 908. An internalperimeter surface 920 surrounding the port 908 may act as a land orvalve seat for when the flow diversion device 900 is in the closedcondition. In the closed condition, a valve flap cuts off flow frominside the user interface 204 to ambient surroundings through the port908.

Flow through the flow diversion device 900 from the inlet of the inletportion 902 to the outlet of the outlet portion 904 pushes against thevalve member 910, which urges the valve member 910 toward the closedcondition. Flow passing from the outlet portion 904 to the inlet portion902 (e.g., in the case of user exhalation) pushes against the valvemember 910 to urge it toward the inlet portion 902 and the openedcondition.

The valve member 910 preferably is cantilevered from the inside surfaceof the wall forming the flow passage. The valve member 910 may be ableto flex toward or away from the closed condition by bending adjacent itsconnection with the wall or by bending along its length. In someconfigurations, the valve member 910, when in the opened condition(i.e., extending into the flow path between the inlet and the outlet),the valve member 910 can bend toward the user during inhalation and/ortoward the flow generator during exhalation. In the illustrated flowdiversion device 900, the secured end of the valve member 910 is clampedbetween two portions of the flow diversion device 900. For example, abase of the valve member 910 may be clamped between an end surface 914of the inlet portion 902 and an end surface 916 of the outlet portion904.

With reference to FIG. 9C, the valve member 910 may be formed integrallywith a gasket 912. The gasket 912 can be a perimeter gasket. In someconfigurations, the gasket 912 only extends a portion of the fullperimeter of the flow diversion device 900. The gasket 912 may besandwiched between the end surfaces 914, 916 around the circumference ofthe connector 900. In the illustrated configuration, the two partscontaining the end surfaces 914, 916 of the flow diversion device 900are secured together by a plurality of screws 930. In otherconfigurations, the two portions of the flow diversion device 900 can besecured by snap fit connection, adhesives, over-moulding, ultrasonicwelding or the like. In some applications, the valve flap 910 is aremovable component.

Where the valve flap 910 displaces by bending along its length, the landor valve seat 920 for the port 908 preferably is disposed on or near aplane that is spaced away from the embedded portion of the valve member.In other words, the land or valve seat 920 is offset in a transversedirection of the illustrated passage such that, as the valve member 910bends to cover the port 908, a portion of the valve member 910 towardthe free end of the valve member 910 can sit against the land 920 andsubstantially close the outlet port 908. The offset advantageouslyallows the valve member 910 to easily cover at least a portion of theoutlet port 908 by simply bending about one bending location. In someapplications, the offset allows the valve member 910 to substantiallycover the outlet port 908 without the valve member 910 having to adopt aconvoluted shape.

In a simple arrangement, the offset is provided by a stepback or offset918 displaced away from the land 920. Instead of the stepback 918, acurved surface may be provided between the base of the valve member 910where it embeds in the wall of the flow diversion device 900 and theport 908. The curved surface may match the expected curvature of thevalve member 910 when it is deflected by prevailing conditions tosubstantially cover the outlet port 908.

In some configurations, the flow passage cross-section in the region ofthe valve member 910 is a substantially square or rectangularcross-section and the valve member 910 comprises a matching but slightlysmaller profile (e.g., square or rectangular shape). Preferably, asignificant gap or space is provided between at least a portion of theperimeter of the valve member 910 and the inner surface of the walldefining the flow passage. The gap or space provides a significant flowpath through the location of the valve 910 with the valve 910 in theopen condition, as illustrated in FIG. 9A. By way of example, withreference to FIG. 9C, the overall flow passage of the illustrated valvecan have a cross-sectional area of about 470 mm2. The valve flap can beabout 16 mm wide and about 19 mm long such that it defines an area ofabout 300 mm2. Thus, the opening between the perimeter of the valve flapand the inner surface of the wall of the flow passage can be about 165mm2. According to such a configuration, with the valve 910 in the openposition, a substantial portion (e.g., slightly more than ⅓) of the flowpath remains unimpinged by the valve. In some embodiments, the valve 910may occlude about 50%, about 60%, about 70% or about 80% of the flowpath. In other words, the valve 910 may occlude between about 50% andabout 80% of the flow path. Preferably, the valve 910 may occludebetween about 50% and 70% of the flow path. In some embodiments, thevalve 910 may occlude between about 60% and about 80% of the flow path.In some embodiments, the valve 910 may occlude between about 60% andabout 70% of the flow path. In some embodiments, the valve 910 mayocclude about 65% of the flow path.

The preferred valve flap 910 is very flexible and can be formed as asingle leaf of a suitable, flexible polymeric material. For example, thevalve flap 910 in the illustrated valve can be made from LSR siliconewith a Shore A hardness of about 40. The illustrated valve flap 910 canbe moulded with a thickness of about 0.45 mm. The 0.45 mm thicknessprovides a sufficiently thin valve flap, wherein the valve flap 910 hada surface dimension of about 16 mm wide by about 19 mm long. Other sizesalso can be used.

The valve port 908 is located downstream of the valve flap 910. Thevalve port 908 may be, for example, about 5 mm downstream to about 10 mmdownstream, and preferably about 7 mm downstream, of the valve flap 910.The illustrated port 908 is approximately trapezoidal in perimetershape, with the shorter of the two parallel sides being closer to thevalve flap 910. In the illustrated embodiment shown in FIGS. 9A-9C, theport 908 has an area of about 86 mm2, a perimeter of about 36 mm2, anoverall width of about 11 mm and an overall length of 8 mm. Thus, thearea of the port 908 may be between about 10% and about 50% of the flowpath, and most preferably between about 15% and about 25% of the area ofthe flow path.

With reference now to FIG. 10A to FIG. 10D, a further flow diversiondevice 1000 is illustrated. As illustrated in FIG. 10A, the flowdiversion device comprises an inlet portion 1002 and an outlet portion1004. The inlet and outlet portions 1002, 1004 can have any suitableconfiguration and can be configured similarly to the inlet and outletportions 902, 904 described above.

A flow passage or bore is defined a body 1005 of the flow diversiondevice 1000 from the inlet portion 1002 to the outlet portion 1004. Acentral portion 1006 of the body 1005 comprises a flow port 1008 thatextends through the wall of the body 1005 of the flow diversion device1000. The flow path through the flow diversion device 1000 cancommunicate with the surroundings through the port 1008.

A flexible valve member 1010 extends into the flow path at a locationbetween the inlet to the inlet portion 1002 and the port 1008. An innersurface 1020 surrounding the port 1008 may act as a land or valve seatfor when the flow diversion device 1000 is in the closed condition. Inthe closed condition, the valve member 1010 generally cuts off flow frominside the user interface 204 to the ambient surroundings through theport 1008.

The port 1008, similar to the port 908, preferably is large enough toenable most of an exhalation flow to pass through the port 1008 into theambient atmosphere. If the port 1008 is too small in area, theexhalation flow will take a path of least resistance around the port1008 and go through the flow diversion device 1000 and the conduitinstead. Because in such an instance, at least a large portion of theexhalation flow remains within the flow diversion device and theconduit, at least a portion of the exhalation flow likely would berebreathed in the next inhalation. This is undesired.

On the other hand, if the port 1008 is too large in area, all of theexhaled gases will flow through the port 1008 to the ambient and therewill be very little of the exhaled gases impinging upon the valve member1010. The valve member 1010, when not positioned over the port 1008,creates a resistance to gases flow from the flow generator 210, 212. Ifthe port 1008 is too large, the flow that urges the port 1008 into aresistance-generating position will be too small and will not beindicative of patient breathing.

Under normal breathing conditions (e.g., a flow of about 25 L/min) andwith a blower operating in a flow control mode with a flow rate of about15-20 L/min, it has been found that the port 1008 preferably has a crosssection of about 90 mm2. In some applications, the port 1008 can have across section of between about 40 mm2 and about 250 mm2. In someapplications, the port 1008 can have a cross section of between about 85mm2 and about 180 mm2. FIG. 11 represents various sizes of ports 1008and the impact on flow rates.

With respect to the valve member 1010, for the valve member 1010 tofunction as a non-rebreathing valve, the size of the valve member 1010preferably is large enough to substantially occlude the flow path fromthe outlet portion 1004 to the inlet portion 1002. If the valve member1010 is too small, the exhalation flow will take the least resistancepath and go down the conduit. If the exhalation flow goes down theconduit, then the exhalation flow likely will be rebreathed on the nextinhalation.

With the valve member 1010 being generally perpendicular to the gasesflow, the resistance to flow from the flow generator can be maximized.Thus, during exahation, a larger valve member 1010 can increase theresistance to flow from the flow generator. It currently is believedthat information regarding a user's breathing can be amplified and thecontroller 224 thereby can receive data having a better resolution witha larger valve member when compared to a smaller valve member or with avalve member without a valve seat when compared to a valve member with avalve seat. The valve member 1010, however, desirably is small enough toallow substantially free movement of the valve member 1010. In theillustrated configuration, the valve member 1010 does not have a seat inthe flow path from the flow generator to the interface.

In the illustrated configuration, the port 1008 is covered with a shroud1040. The shroud 1040 extends around at least a portion of the outersurface of the body 1005. In some configurations, the body 1005 isgenerally cylindrical and the shroud 1040 extends around a portion ofthe circumference of the body 1005. In the illustrated configuration,the shroud 1040 extends around an outer surface of the central portion1006 of the body 1005. The shroud 1040 has a first end and a second end1041 that define openings 1042. Gases passing out of the port 1008 passthrough a passage defined between the illustrated shroud 1040 and thecentral portion 1006 of the body 1005 and are exhausted to the ambientatmosphere through the openings 1042. Similarly, air can pass throughthat same passage, into the port 1008 and into the flow diversion device900.

Other valve constructions also are possible without departing from thegeneral scope of the present invention. In some configurations, valvescan be used that are similar to those described in U.S. ProvisionalPatent Application No. 61/504,295, filed Jul. 4, 2011 with AttorneyDocket No. FPHCR.270PR2, which is hereby incorporated by reference inits entirety. In addition, the Quattro anti-asphyxia valve by ResMed hassuitable characteristics, although not as good as the valve describedwith reference to FIGS. 9A to 9C. Other valve constructions may bedevised that meet the desired functional criteria for opening andclosing with respect to the prevailing conditions in a stable manner.These preferred functional aspects will be apparent from the discussionbelow with reference to FIGS. 5, 6, 7 and 8.

Example Tests of Values and Systems

Behaviour of systems that have been arranged and configured inaccordance with certain features, aspects and advantages of the presentinvention (e.g., utilising the valve described with reference to FIGS.9A-9C and also an alternative commercially available valve) aredescribed below. The tests demonstrated comparative performance of thevalves and comparative performance of different control methods whenused with the valves. Tests were conducted using a test setup asillustrated in FIG. 4.

The test setup illustrated in FIG. 4 comprises a CPAP flow generator 402that is connected to deliver flow to an artificial lung 404. The CPAPflow generator 402 used in the experiments described herein was a Fisher& Paykel ICON Auto available from Fisher & Paykel Healthcare Limited,Auckland, New Zealand. The CPAP flow generator 402 featured modifiedsoftware that was modified to remove lower limits. The artificial lungwas an ASL5000 available from Ingmar Medical Ltd of Pittsburgh, USA.

The CPAP flow generator 402 was connected to the artificial lung 404 viaa delivery conduit 406. The delivery conduit 406 was the 1.8 m supplyhose supplied with the ICON Auto.

Between the user end of the delivery conduit 406 and the inlet port ofthe artificial lung were, in series, the valve 408 being tested, a biasflow connector 410, and a connector 412 including a port 414 formeasuring characteristics of the gases stream. The bias flow connector410 was an elbow from an HC407 nasal mask available from Fisher & PaykelHealthcare Limited. In the illustrated setup, the port 414 of theconnector 412 was connected to a data acquisition unit 416 for measuringpressure at the entrance to the artificial lung. Additional datacollected by the CPAP flow generator 402, including delivered flow, wassupplied to a data interface box 418 and on to data acquisition unit416. The collected data from data acquisition unit 416 was provided to acomputer 420 or other suitable processing unit. The computer 420 can beconnected to the artificial lung 404 to provide control signals to theartificial lung 404 and to the CPAP flow generator 402 to providecontrol signals to the CPAP flow generator 402.

Testing of Valve Characteristics Under Different Control Modes

In a first set of tests, the apparatus shown in FIG. 4 was used toconsider the characteristics of the valve shown in FIGS. 9A-9C and thecharacteristics of an existing anti-asphyxia valve. These tests showboth comparative performance of the valves and comparative performanceof the control methods. The existing anti-asphyxia valve is suppliedwith the ResMed Quattro Full Face User Interface (available from ResMedPty Limited of Sydney, Australia). The tests demonstrate some of theadvantages of the preferred control (i.e., the control as used witheither valve) and some of the advantages in this application of thevalve of FIGS. 9A-9C over the ResMed anti-asphyxia valve.

For each valve, two series of tests were conducted. For each test ineach series, the artificial lung was set up to run through a breath testsequence including: (1) four breaths at 250 ml tidal volume; (2) pause;(3) four breaths at 500 ml tidal volume; (4) pause; (5) four breaths at750 ml tidal volume; (6) pause; (7) and four breaths at 1000 ml tidalvolume. All breaths were sinusoidal at 15 breaths per minute with a 1:1expiration to inspiration ratio.

In the first test series, the CPAP flow generator 402 was controlled torun at a constant motor speed for the duration of each test. That is,the device ran without pressure or flow feedback control. The device 402was set to run at a speed at which the delivered average flow wasexpected to be low and the valve 408 open. The breath sequence wasplayed and the behaviour of the valve 408 was noted. The speed wasincreased by 1000 rpm and the process was repeated. This cycle wascontinued, increasing the speed by 1000 rpm each time until the valve408 reached a stable closed state. Then the process was repeated,reducing the speed by 1000 rpm in each of the test sequences until thevalve 408 reached a stable open state. At each of the tests, thebehaviour of the valve 408, the average mask pressure and the averageflow rate were recorded.

For the valve illustrated in FIGS. 9A-9C, the results of this sequenceof tests are illustrated in FIGS. 5A-5C. These figures are discussed inmore detail below. For the ResMed Quattro valve, the results of thissequence of tests is illustrated in FIGS. 6A-6C. These results arediscussed in more detail below.

In the second sequence of tests on each valve 408, the CPAP flowgenerator 402 was run in a pressure feedback mode. The first test in thesequence had the set pressure for the flow generator at 1 cm H2O.Subsequent tests were conducted at increasing pressures, increasing theset pressure by 0.5 cm H2O for each subsequent test. Once the valve 408reached a stable closed state, the process was repeated in reverse,reducing the set pressure by 0.5 cm H2O for each subsequent test. Foreach test, the state of the valve 408, the average flow and the averagepressure were recorded. The results of this testing for the valve ofFIGS. 9A-9C are illustrated in FIGS. 5D-5F. The results of this testingfor the ResMed Quattro valve are illustrated in FIGS. 6D-6F.

Test Results for Valve of FIGS. 9A-9C

FIGS. 5A to 5C illustrate the behaviour of the valve 408 shown in FIGS.9A-9C (i.e., the flow diversion device 900) under constant flowgenerator speed conditions. This illustrates, for example, the way thevalve 408 will behave when the flow generator 402 is controlled withslow feedback based on average flow. The flow generator 402 will notreact to the breathing cycle changes in flow or pressure and, over asequence of breaths, will maintain essentially a constant flow generatorspeed. The instantaneous flow and pressure will fluctuate as the userbreathes. FIG. 5B, which indicates the measured pressure, and FIG. 5C,which indicates the measured flow, both represent the average of thepressure or flow over the breaths of the test. The valve state behaviourin FIG. 5A was by observation. Either the valve 408 remained closedacross all of the sequence of breaths, the valve 408 remained openacross all of the sequence of breathes, or was instable and movedbetween the open and closed states in response to the breathing cycle.

The sequence of tests is indicated by the sequence of data points 501,502, 504, 506, 508, 510, 512, 514, 516, 518. For simplicity, thissequence of data points is indicated by the same reference numerals ineach of FIGS. 5A, 5B and 5C.

In FIG. 5A, it can be seen that the behaviour of the illustrated valve,when commencing in the open state, remains stable in the open state atblower speeds of 3000, 4000 and 5000 rpm (data points 501, 502 and 504in FIG. 5A). At these blower speeds, the pressure delivered to theartificial lung remains below about 1.5 cm H2O (data points 501, 502 and504 in FIG. 5B). Also within this range, the delivered flow at 3000 rpmwas above about 15 litres per minute and the delivered flow at 5000 rpmabove about 30 litres per minute. Accordingly, the illustrated valveprovides for substantial adjustment of the delivered flow to compensatefor large bias flow vents or leaks at the mask without excessivelyincreasing the delivered sub-therapeutic pressure and with the valvestaying stable in the open position.

With the illustrated valve of FIGS. 9A-9C and the illustrated flowgenerator, when reducing the output of the flow generator in response touser awakening, and subsequently entering the constant average flow(i.e., constant rotor speed) mode, the initial flow generator speedshould be at or below 4000 rpm so that the valve exhibits the initialstable behaviour (see, for example, the transition between data points516 and 518 in FIG. 5A).

FIGS. 5D-5F illustrate the results of testing in the pressure feedbackmode. As discussed above, the pressure feedback mode is entered toprovide therapeutic pressures once the user is asleep. One preferablecharacteristic of the valve illustrated in FIGS. 9A-9C is to exhibitstable closed behaviour under pressure feedback control at a setpressure that is close to the average mask pressure deliveredimmediately prior, when the valve behaviour was stable open underconstant rotor speed control.

With reference to data points 520 and 524, the valve of FIGS. 9A-9Cexhibits unstable behaviour with the pressure feedback control at 1 cmH2O set pressure whether commencing at this set pressure or returning tothis set pressure from higher set pressure. However, as indicated bydata point 522, at 1.5 cm H2O set pressure, the valve exhibits stablebehaviour. At this set pressure, the system delivered an averagepressure of about 1.7 cm H2O and delivered an average flow of about 20litres per minute.

Performance of the Valve of FIGS. 9A-9C in Combination with PreferredControl Modes

The delivered average mask pressure with the valve stable and closed(e.g., about 1.7 cm H2O) is less than about 1 cm H2O higher than thedelivered average mask pressure under the constant rotor speed controlwith the valve stable open (data points 501, 502 and 504 in FIG. 5B).The delivered average flow at this setting is within the range of thedelivered average flow indicated by data points 501, 502 and 504 in FIG.5C.

Data point 522 relates to the valve stable and closed (i.e., pressuremode) and generates a mask pressure of about 1.7 cm H2O. Data point 518relates to the valve stable and open (i.e., speed mode) and generates amask pressure of about 0.9 cm H2O. The delivered average mask pressurewith the valve stable and closed (about 1.7 cm H2O) can be less thanabout 1 cm H2O higher than the delivered average mask pressure under theconstant rotor speed control with the valve stable open (i.e., datapoints 501, 502 and 504 in FIG. 5B). The delivered average flow at thissetting can be within the range of the delivered average flow indicatedby data points 501, 502 and 504 in FIG. 5C.

Accordingly, using the illustrated valve and flow generator controlcombination, the system may move from the sub-therapeutic mode, with aflow generator speed of about 4000 rpm delivering about 0.9 cm H2O,average mask pressure and about 25 litres per minute average flow, to atherapeutic mode, with pressure feedback control, delivering about 1.7cm H2O average mask pressure and about 20 litres per minute averageflow.

When switching from the therapeutic delivery mode to the sub-therapeuticdelivery mode (e.g., in response to user awakening), one could expectgenerally the same transition between system conditions, but in reverse.

Test Results for ResMed Anti-Asphyxia Valve

FIGS. 6A to 6C illustrate the behaviour of the ResMed Quattro valveunder constant flow generator speed. This illustrates the way the valvewill behave where the flow generator is controlled with slow feedbackbased on average flow, such as in the preferred sub-therapeutic modeaccording to certain features, aspects and advantages of the presentinvention. FIG. 6A illustrates the observed valve state in each of thetests. FIG. 6B indicates the average measured pressure in each of thetests and FIG. 6C illustrates the average measured flow in each of thetests. The sequence of the tests is indicated by the sequence of datapoints 600, 602, 604, 606, 608, 610, 612, 614, 616. For simplicity, thissequence of data points are indicated by the same reference numerals ineach of the FIGS. 6A, 6B and 6C.

From FIG. 6A, it can seen that the behaviour of the ResMed Quattro valvewhen commencing in the open state remains stable in the open state atblower speeds of 3000 rpm, 4000 rpm, 5000 rpm (data points, 600, 602 and604). At these blower speeds, the pressure delivered to the artificiallung is approximately 1 cm H2O (data points 600, 602 and 604 in FIG.6B). The delivered flow at 4000 rpm is about 20 litres per minute andthe delivered flow at 5000 rpm is about 30 litres per minute. However,the delivered flow at 3000 rpm is only about 10 litres per minute, whichis lower than desirable. Accordingly, the average flow rate across therange of flow generator speed at which the ResMed Quattro valve isstable is approximately 10 litres per minute to 30 litres per minutecompared to approximately 15 litres per minute to 35 litres per minutefor the valve of FIGS. 9A-9C.

Referring to FIGS. 6D to 6F, these figures illustrate the results oftesting in the pressure feedback mode. With reference to data points620, 622, 624, 626, the ResMed Quattro valve exhibits unstable behaviourwith the pressure feedback control at a 1 cm H2O set pressure whethercommencing at this set pressure or returning to this set pressure from ahigher set pressure. The valve remains unstable at 1.5 cm H2O setpressure (data points 622 and 626 in FIG. 6A). The valve exhibits stablebehaviour once the set pressure reaches 2 cm H2O (data point 624 in FIG.6A). With a set pressure of 2 cm H2O, the delivered average pressure wasabout 2.2 cm H2O (data point 624 in FIG. 6E). At 2 cm H2O, the deliveredaverage flow rate was about 15 litres per minute (data point 624 in FIG.6F).

Performance of the ResMed Valve in Combination with the PreferredControl Mode

The delivered average mask pressure with the ResMed Quattro valve at thelowest set pressure for stable closed valve behaviour is approximately1.2 cm H2O above the delivered average mask pressure under constantspeed control with the valve open. The delivered average flow rate is atthe lower end of the average flow rate range using motor speed control.

Using this valve and flow generator combination, one could expect totransition from the sub-therapeutic mode (i.e., with a flow generatorspeed of about 4000 rpm), delivering about 1 cm H2O average maskpressure and about 20 litres per minute average flow, to a therapeuticmode with pressure feedback control, delivering about 2.2 cm H2O maskpressure and about 15 litres per minute average flow. When switchingfrom a therapeutic delivery to the sub-therapeutic delivery, one couldexpect the same transition between system conditions but in reverse.

Comparison of FIGS. 9A-9C Valve Performance with ResMed ValvePerformance

Both the valve of FIGS. 9A-9C and the ResMed valve provide adequateperformance in conjunction with the preferred control—switching from anopen loop control to a pressure feedback control—at the transition fromsub-therapeutic to therapeutic modes. In each case, the delivered flowsat the transition are sufficient and the pressure step is reducedcompared with the same transition under pressure feedback only control.However, the valve of FIGS. 9A-9C provided a lower step in mask pressure(e.g., about 0.8 cm H2O) when compared with the ResMed valve (e.g.,about 1.2 cm H2O) and provided a greater flow at both thesub-therapeutic and the therapeutic pressures around the transition.

Comparison Using the Example Control Method in a Sequence of SimulatedBreaths

The effect of particular valve behaviour can be seen in the results ofthe additional test sequence executed on each of the ResMed Quattrovalve and the valve of FIGS. 9A-9C. According to the second testsequence, the artificial lung was set up to simulate continuousbreathing at 1000 ml tidal volume, with all breaths sinusoidal at 15breaths per minute with a one-to-one expiration to inspiration ratio.The flow generator was controlled to commence with a constant speed of3000 rpm. After a period of time, the flow generator was switched to apressure feedback mode with a set pressure of 1.5 cm H2O. Throughout thetest, the valve behaviour was observed and the delivered flow (i.e., theflow leaving the flow generator) and the pressure at the artificial lungwere recorded.

FIG. 7A plots the pressure and flow versus time for the ResMed Quattrovalve. FIG. 7B plots the pressure and flow versus time for the valve ofFIGS. 9A-9C.

Referring in particular to FIG. 7A, the pressure plot shows a firstportion 708 while the flow generator is in constant speed mode and asecond portion 714 after the flow generator transitions to pressurefeedback mode with a set pressure of 1.5 cm H2O at time 702. With theflow generator in constant speed mode at portion 708, the pressurefluctuates with the sinusoidal breathing pattern imposed by theartificial lung. After the transition to pressure feedback mode, thepressure feedback control is trying to assert control over the pressureand reduces the influence of the imposed breathing.

In the flow plot, portion 710 precedes the transition 702 and portion712 is after the transition 702. In portion 710, the flow fluctuateswith user breathing approximately opposing the fluctuation of pressure.As the artificial lung exhales, the pressure rises and the deliveredflow reduces. As the artificial lung inhales, the pressure drops and thedelivered flow increases.

After the transition 702, the delivered flow 712 remains in phase withthe user breathing. The delivered pressure 714 is more complex, as thefeedback control tries to respond to the instantaneous pressure.

One feature of these plots is that the set pressure of 1.5 cm H2O hasnot been sufficient to bring this valve into a stable, closed condition.This is illustrated by the highlighted spikes 704 in the pressure plotand the highlighted irregularity 706 in the flow plot. The spike 704 andthe irregularity 706 occur in each breath in the sequence after enteringthe pressure feedback mode. The spikes and irregularities indicate thatthe valve is unstable at 1.5 cm H2O and correspond with the valvesnapping shut. The valve then reopens at some point in the cycle andsnaps shut again at the start of the next exhalation.

FIG. 7B shows similar plots for the valve illustrated in FIGS. 9A-9C.Again, the plots include portions 720, 722 prior to a transition 724 tothe pressure feedback control with a set pressure of about 1.5 cm H2O.For this valve, the difference in average pressure between the period720 prior to the transition 724 and the period 726 after the transition724 is lower than the difference in average pressure during the period708 and average pressure in period 714 for the ResMed Quattro valve.Despite this, the valve of FIGS. 9A-9C has entered a stable closedcondition at moment 728 and, as indicated at 730, there are noconspicuous spikes in the pressure plot and no significant discontinuitypeaks or irregularities of the flow curve. This corresponds with theobservation that the valve had entered a stable, closed condition.

Thus, the valve of FIGS. 9A-9C outperforms the ResMed anti-asphyxiavalve by achieving stable closed behaviour at a lower delivered pressureand with a smaller increase in system conditions from a stable opencondition.

FIGS. 8A and 8B illustrate different characteristics under open loopcontrol and under pressure feedback control for the valve of FIGS.9A-9C. FIG. 8A illustrates features that correspond to valveinstability. FIG. 8B illustrates the effect of pressure feedback on flowfluctuation. Both FIG. 8A and FIG. 8B relate to the valve in the closedstate. The sequence was run firstly with the flow generator controlledto have a constant rotor speed of 5000 rpm. In the second test, the flowgenerator was operated in a pressure feedback mode with a set pressureof 1.5 cm H2O.

The behaviour of the valve of FIGS. 9A-9C was observed in the two modes.Furthermore, the flow and pressure were recorded throughout the tests.

FIG. 8A provides flow and pressure versus time plots for the testconducted with open loop control and with the CPAP speed controlled at5000 rpm. FIG. 8B shows the pressure and flow versus time plots withpressure feedback control and with the CPAP flow generator pressure setto about 1.5 cm H2O.

FIG. 8A illustrates that the illustrated valve is becoming unstable witha blower speed at 5000 rpm having previously been higher. Instability inFIG. 8A is indicated by the pressure spike 802 becoming apparent in theearly part of expiration in each breath.

This can be compared with the performance of the valve recorded in FIG.8B in the pressure control mode. In the pressure control mode, with aset pressure of 1.5 cm H2O, there are no large transient peaks in thepressure curve, indicating that the valve is stable. However, the peakto peak flow fluctuation is much greater than the flow fluctuation inthe open loop control mode illustrated in FIG. 8A.

Overview of Operating Characteristics of Flow Diversion Device andControl Techniques

Desirably, the flow diversion device and the control of the flowgenerator work in cooperation with one another. In some configurations,with the flow generator not generating flow, the user will inhaleambient air through the port of the flow diversion device and exhale airmostly out to ambient through the port. During exhalation, some smallportion of the exhaled gases may push the valve member to bend the valvemember downward toward the flow generator and a small portion of theexhaled gases may travel down the conduit beyond the valve member.

In some configurations, with the flow generator generating asub-therapeutic flow of gases (i.e., flow control mode), the user willinhale mostly ambient air through the port while the flow from the flowgenerator bends the valve slightly toward the user and, as such,provides a small portion of flow to the user. During exhalation, most ofthe exhalation passes through the port with some portion of theexhalation moving the valve member back toward the flow generator, whichslows the flow from the flow generator. Dependent upon the exhalationflow from the user, the flow rate from the user may vary. Thus, thevarying flow rate may be indicative of the user breathing, which enablesthe controller 224 to monitor breathing patterns and identify events(e.g., apnea).

In some configurations, with the flow generator generating a therapeuticflow of gases (i.e., pressure control mode), during inhalation, thevalve member overlies the port and the user breathes gases from the flowgenerator. During exhalation, the user breathes against the flow fromthe flow generator and the valve member overlies the port.

Although certain features, aspects and advantages of the presentinvention have been described in terms of a certain embodiments, otherembodiments apparent to those of ordinary skill in the art also arewithin the scope of this invention. Thus, various changes andmodifications may be made without departing from the spirit and scope ofthe invention. For instance, various components may be repositioned asdesired. In addition, certain features, aspects and advantages of theinvention have been described with reference to breathing gases supplydevices particularly for use in the treatment of obstructive sleepapnea. PAP devices also are used in the treatment of other conditions,such as COPD, and may be used for the supply of mixed gases other thanair, for example, a mixture of air and oxygen, or a mixture of nitrogenand oxygen or the like. The method and apparatus of the presentinvention may be equally applied to gas supply apparatus for use inthese other treatments. Moreover, not all of the features, aspects andadvantages are necessarily required to practice the present invention.Accordingly, the scope of the present invention is intended to bedefined only by the claims that follow.

1.-32. (canceled)
 33. A flow diversion device comprising: an inletportion comprising an inlet connector portion, an outlet portioncomprising an outlet connector portion, a flow path provided through abody from an inlet end of the inlet portion to an outlet end of theoutlet portion, a central portion comprising a flow port extendingthrough a wall of the flow diversion device, wherein the flow paththrough the flow diversion device can communicate with ambientsurroundings through the flow port, a flexible valve member that extendsinto the flow path at a location between the inlet end of the inletportion and the flow port, wherein the wall defines an inner surface ofthe flow path, the inner surface comprising an internal perimetersurface surrounding the flow port that acts as a valve seat when theflow diversion device is in a closed condition, wherein the flowdiversion device is configured such that flow through the flow diversiondevice from the inlet end of the inlet portion to the outlet end of theoutlet portion pushes against the flexible valve member to urge theflexible valve member toward the closed condition, wherein the flowdiversion device is configured such that flow through the flow diversiondevice from the outlet portion to the inlet portion pushes against theflexible valve member to urge it toward the inlet portion and an openedcondition, wherein a gap is provided between at least a portion of theperimeter of the flexible valve member and the inner surface of thewall, and wherein a substantial portion of the flow path is unimpingedby the flexible valve member in the opened condition.
 34. The flowdiversion device of claim 33, wherein the flexible valve membercomprises a matching but slightly smaller profile than the flow pathcross section in the region of the flexible valve member.
 35. The flowdiversion device of claim 34, wherein the flow path cross section in theregion of the flexible valve member is substantially rectangular. 36.The flow diversion device of claim 33, wherein the flow port is locateddownstream of the flexible valve member.
 37. The flow diversion deviceof claim 33, wherein the flexible valve member is cantilevered from theinside surface of the wall forming the flow path.
 38. The flow diversiondevice of claim 33, wherein the flexible valve member is able to flextoward or away from the closed condition by bending adjacent itsconnection with the wall forming the flow path or by bending along itslength.
 39. The flow diversion device of claim 33, wherein a secured endof the flexible valve member is clamped between two portions of the flowdiversion device.
 40. The flow diversion device of claim 33, wherein theflexible valve member is formed as a single leaf.
 41. The flow diversiondevice of claim 33, wherein the flexible valve member is formed of aflexible polymeric material.
 42. The flow diversion device of claim 33,wherein an area of the flow port is between about 10% and about 50% ofthe flow path.
 43. The flow diversion device of claim 33, wherein whenin the opened condition, the flexible valve member is configured to bendtoward a flow generator during exhalation.
 44. The flow diversion deviceof claim 33, wherein the flexible valve member comprises an embeddedportion.
 45. The flow diversion device of claim 44, wherein the valveseat is disposed on or near a plane that is spaced away from theembedded portion.
 46. A system comprising: a flow generator, a userinterface, a supply conduit connecting the supply device and the userinterface, and the flow diversion device of claim
 33. 47. The system ofclaim 46, wherein the flow diversion device is located at or generallyadjacent to the user interface.